21 CFR Part 11 compliant · HIPAA-ready infrastructure

Clinical trials management built for modern research teams

From protocol activation to closeout — Orbitrials connects sponsors, sites, and monitors on one auditable platform. No spreadsheets, no gaps.

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No credit card required. Full access for 14 days.

ICF Version Control

Track informed consent versions, participant compliance, and amendment re-consent in one place. Never miss a consent gap.

Visit Scheduling

Schedule visits, track window compliance, capture CRF data, and reschedule with a single click. Full audit trail on every change.

Dynamic Inventory

Forecasts demand from scheduled visits automatically. No manual minimum stock — the system tells you when to reorder.

Enrollment Metrics

Screen failure rate, enrollment velocity, completion rate, and LTFU — live charts updated as participants progress.

eCRF Automation

Auto-populate CRF fields from prior entries, flag outliers in real time, and export directly to EDC — saving coordinators hours per visit.

21 CFR Part 11

Dual-signature delegation logs, e-signature audit trail, append-only audit tables, and role-based access enforcement throughout.

Reporting Logs

Audit-ready deviation logs, adverse event reports, and protocol compliance summaries — one click to inspection-ready exports.

Sponsor Notifications

Sponsors receive real-time alerts on protocol deviations, adverse events, and enrollment milestones — no waiting for site reports.

Built for every role in the trial

One platform — purpose-built views for sites and sponsors so everyone has exactly what they need, nothing they don't.

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For Sites

Coordinators, nurses, investigators

Visit Management
See your full schedule at a glance. Window violations are flagged automatically before they become protocol deviations.
eCRF Entry
Structured data capture activity by activity. No paper binders — enter, lock, and sign from any device in the clinic.
Coordinator Efficiency
Delegation logs, task assignments, and protocol access are always current — no chasing down paper forms or email threads.
ICF & Compliance
Re-consent alerts appear the moment an ICF amendment is published. Log consent with an e-signature in seconds.

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For Sponsors

CROs, monitors, medical affairs teams

Real-Time Notifications
Instant alerts on deviations, SAEs, IMP discrepancies, and missed visits — pushed to the right person the moment they occur.
Oversight & Data Visibility
Cross-site enrollment dashboards, query resolution rates, and protocol compliance metrics — all without waiting for weekly reports.
Regulatory Compliance
Every delegation, signature, and data change is logged immutably. Sponsor can export audit-ready packages directly for inspections.
Invoice & Budget Management
Site invoices are auto-generated from completed visits and milestones. Full CTA reference, line-item detail, and one-click PDF.

Compliance-grade pricing, built to scale

Every plan includes 21 CFR Part 11 & HIPAA compliance infrastructure. Start with a free trial — no credit card required.

One-time Validation & Compliance Setup Fee — $1,500

Covers account provisioning, MSA generation, and 21 CFR Part 11 validation certificate tracking. Required before production activation. Billed once at onboarding.

Site Starter

$499/month

Independent research clinics

1 active Site Profile
5 User Seats
Patient Check-in
Standard DoA / Delegation Logs
AE & Deviation Reporting
Immutable Audit Logs

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